Ciclopirox Solution
NDC Package 62135-814-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ciclopirox solution is a medication used to treat fungal infections of the fingernails and toenails. This formulation utilizes a solution delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-814 and is authorized under FDA application ANDA078046.

Identification & Billing

NDC Package Code
62135-814-45
Package Description
6.6 mL in 1 BOTTLE
Product Code
62135-814
11-Digit Billing Format
62135081445
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
6.6 ML

Clinical Specifications

Proprietary Name
Ciclopirox
Non-Proprietary Name
Ciclopirox
Substance Name
Ciclopirox
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
CICLOPIROX 71.3 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078046
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2007
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62135-814-45 identifies a specific commercial package of 6.6 ml in 1 bottle of Ciclopirox, a human prescription drug labeled by Chartwell Rx, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 6.6 billable units per package. This solution is formulated for topical use and contains ciclopirox as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chartwell Rx, Llc on September 18, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135081445. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 6.6 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
62135-814-45
11-Digit CMS (5-4-2)
62135-0814-45

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.